三鑫醫療(300453.SZ):子公司取得醫療器械註冊證 分別為一次性使用血液透析器、透析機消毒液
格隆匯12月26日丨三鑫醫療(300453.SZ)公佈,公司全資子公司四川威力生醫療科技有限公司(“四川威力生”)於近日取得了國家藥品監督管理局頒發的《醫療器械註冊證》,產品名稱分別為一次性使用血液透析器,透析機消毒液。
四川威力生本次獲得醫療器械註冊證的一次性使用血液透析器由空心纖維膜、外殼、血蓋、封口膠、密封圈、護帽組成,空心纖維膜材料為聚醚碸(PES),外殼和血蓋材料為聚碳酸酯(PC),封口膠材料為聚氨酯(PU),密封圈材料為合成橡膠,護帽材料為聚乙烯(PE),經輻照(γ射線)滅菌,一次性使用。此次獲得醫療器械註冊證的透析機消毒液由枸櫞酸、乳酸、D,L-蘋果酸和純化水組成或枸櫞酸和純化水組成。
此次是四川威力生首次獲得一次性使用血液透析器醫療器械註冊證,對公司逐步完善產品及業務的戰略區位佈局具有重要意義,有利於進一步提升公司產品綜合效益及公司的競爭實力;本次獲證的透析機消毒液可配套血液透析機使用,將進一步補充公司產品鏈,對公司的未來發展將產生積極影響。
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